5
Dec 22
The European Commission sends a Statement of Objection to a drug manufacturer accusing it of regulatory gaming and denigration of competitors in breach of Article 102 TFEU
On October 10, 2022, the European Commission sent a Statement of Objection to Teva accusing the company of denigrating a competing product and of “regulatory gaming” in management of the life cycle of its multiple sclerosis drug Capoxone, conduct deemed abusive pursuant to Article 102 of the Treaty on the Functioning of the European Union.
1
Sep 22
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
16
Nov 21
Draft competition bill: New rules for the healthcare sector?
On November 5, 2021, the Council of Ministers approved the draft law on competition. The Competition Bill is now under review by Parliament, which will discuss the draft in the coming weeks.
14
Sep 21
Pharmaceutical company liability in clinical trials: The italian supreme court’s latest decision
On April 20, 2021, the Italian Supreme Court dealt with a complex and much debated matter: pharmaceutical company liability for damages to a participant in a sponsored clinical trial.
12
Apr 21
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
3
Dec 20
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.
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